|Survey Date: 5/25/2010|
Regulation Title: MD RESP-MED DIR QUAL/ACCOUNTABLE TO GOV BODY
Regulation Description: The dialysis facility must have a medical director who meets the qualifications of §494.140(a) to be responsible for the delivery of patient care and outcomes in the facility. The medical director is accountable to the governing body for the quality of medical care provided to patients.
Based on staff interviews and review of facility documents, it was determined that the facility failed to ensure that the Medical Director was involved in the resolution of quality issues identified in the quality improvement program.
The findings were:
An interview with the facilities Medical Director was conducted on 5/18/10 at approximately 1:35 PM. S/he stated that there was an incident on 2/24/10 in which a patient was placed on a dialysis machine with another patient's dialyzer. The patient to whom the dialyzer belonged was determined to have active Hepatitis C.
A review of the facilities internal documents was conducted on 5/19/10.
Minutes from the Quality Improvement & Facility Management Meeting (QIFMM) dated 3/2/10 were reviewed. The only mention of the wrong patient dialyzer being used was in a section titled "Adverse Occurrence Reporting". No plan was identified in that section, nor was a priority level selected where available to do so. On the last page of the QIFFM minutes, in the additional review items/notes page, is written, "Home room lesson to be held re: Dialyzer identity, Team mate meeting re policy 1-03-01, 1-03-02, 1-03-04A".
An agenda of the Team Meeting, dated 3/18/10, was reviewed. The agenda contained an agenda topic of "Dialyzer Verification" that was scheduled for five minutes of the meeting. The minutes from the meeting state, in pertinent part: "...The reuse dialyzer needs to be visually verified by 2 teammates and documented...Failure to not verifying dialyzer and patient match is VERY SERIOUS and result in patient injury..."
The facilities policies were reviewed on 5/19/10. The policies referred to in the QIFMM minutes were not revised after the incident on 2/24/10.
In summary, after the facility had identified that an error took place in which a dialyzer from one patient was used on another patient, the facility's Medical Director did not make any changes to the facility's policies or procedures. There was no evidence that the Medical Director was involved in the efforts to prevent an error similar to the one identified from occurring again.
Facility Plan of Correction:
The Medical Director is accountable to the
GB and will ensure the security of medical
records, be involved in the quality
improvement process in evaluation and
prevention of medical errors, and ensure
teammates adhere to policies and
procedures. Adverse occurrences will be
reviewed in QIFMM meeting with action
plans developed and implemented as
needed. Policy changes will be made if
indicated. After internal review of cited
incidents a plan of action was put in place
that required that the teammate not sign off
dialyzer until the patient is in their chair.
Policy # 01-03-02 “Prescription
Verification and Safety Checks” was
revised to include written verification on
the dialyzer while the patient is present, by
2 teammates. A governing body meeting
which included the Medical Director was
held on 05/20/2010 approving the new
policy. Documentation of this meeting is
on file in the facility. All teammates were
in-serviced on this policy on 05/21/2010
and 05/22/2010. The Charge Nurse/
Clinical Coordinator is observing the
PCT's for compliance with verification
while the patient is in the chair. In
addition, auditswill be conducted on 100%
of reuse dialyzers X 1 month followed by
auditing of 50% of reuse dialyzers X 1
month, to ensure compliance. The dialyzer
audits were implemented on 06/08/2010.
These audits are being conducted by the
reuse technician and given to the FA for
review daily. Results of audits will be
reported in QIFMM and addressed as
necessary. The Clinical Services Specialist (CSS) will have pre QAPI and QIFMM meetings with the FA's X 6 months to ensure all plans of correction are documented correctly.
Clinical Services Specialist (CSS) to attend
QAPI meetings X 6 months to ensure
Medical Director Participation.
Administrative Assistant (AA) will attend
QAPI meetings to record the meeting and
POC's developed by the IDT during the
meetings. FA and Medical Director are
responsible for ongoing compliance with